A Proposed Staging System and Stage-Specific Interventions for Familial Adenomatous Polyposis | oneFAPvoice

If you are a doctor or other qualified health care professional, you should not offer any medical advice or treatment on our Sites, nor should you allow the content of our Sites to substitute for your own medical judgment. Please thoroughly review the information provided on our Sites before deciding whether any of the products, services, or treatments therein are right for you or others.

registration:

oneFAPvoice* required fields

how do you identify as a member of the FAP or rare disease community? *

suggest a poll

DISCLAIMER

The information and materials accessed through or made available for use on any of our Sites, including, any information about diseases, conditions, treatments, or medicines, are for informational purposes only. The Content is not intended to be and is not a substitute for professional medical advice, diagnosis, or treatment, and your participation on our Sites does not create a healthcare professional-patient relationship. You should consult a doctor or other qualified health care professional regarding any questions you have about your health or before making any decisions related to your health or wellness. Call your doctor or 911 immediately if you think you may have a medical emergency.

BACKGROUND : It is not possible to accurately count adenomas in many patients with familial adenomatous polyposis (FAP). Nevertheless, polyp counts are critical in evaluating each patient’s response to interventions. However, the U.S. Food and Drug Administration no longer recognizes the decrease in polyp burden as a sufficient chemoprevention trial treatment endpoint requiring a measure of “clinical-benefit.” To develop endpoints for future industry-sponsored chemopreventive trials, the International Society for Gastrointestinal Hereditary Tumors (InSIGHT) developed an FAP staging and intervention classification scheme for lower GI tract polyposis.

METHODS : Twenty-four colonoscopy or sigmoidoscopy videos were reviewed by 26 clinicians familiar with diagnosis and treatment of FAP. The reviewers independently assigned a stage to a case using the proposed system and chose a stage-specific intervention for each case. Our endpoint was degree of concordance among reviewers staging and intervention assessments.

RESULTS : The stage and intervention ratings of the 26 reviewers were highly concordant (ρ = 0.710; 95% credible interval, 0.651-0.759). Sixty-two percent of reviewers agreed on FAP stage, and 90% of scores were within ±1 stage of the mode. Sixty percent agreed on the intervention, and 86% chose an intervention within ±1 level of the mode.

CONCLUSIONS : The proposed FAP colon polyposis staging system and stage-specific intervention is based on a high degree of agreement on the part of experts in the review of individual cases of polyposis. Therefore, reliable and clinically relevant means for measuring trial outcomes can be developed. Outlier cases showing wide scatter in stage assignment call for individualized attention and may be inappropriate for enrollment in clinical trials for this reason.

organisation:
The University of Texas MD Anderson Cancer Center, West Virginia University Health Sciences Center, University of Bologna, Saitama Medical University, Hospital Sirio Libanes, University of Barcelona, University of Michigan Health System, Washington University School of Medicine, Istituto Nazionale dei Tumori, St. Marks Hospital, University of Utah, University of Colorado School of Medicine, Hyogo College of Medicine, Hvidovre University Hospital, The Ohio State University, Memorial Sloan-Kettering Cancer Center, Aalborg Universitetshospital, Harvard Medical School, University Witten-Herdecke